Hyperbaric Oxygen Therapy for Antibiotic Refractory Pouchitis
HBOT-pouch
1 other identifier
interventional
20
1 country
1
Brief Summary
The aim of current study is to evaluate the effect of hyperbaric oxygen therapy for the treatment of chronic antibiotic-refractory pouchitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 14, 2018
CompletedFirst Posted
Study publicly available on registry
May 16, 2018
CompletedStudy Start
First participant enrolled
June 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2020
CompletedMay 16, 2018
May 1, 2018
1.9 years
April 14, 2018
May 15, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Remission rate
Defined by a pouchitis disease activity index (PDAI) score of \< 7 points
up to 4 weeks
Secondary Outcomes (8)
Response rate
up to 4 weeks
Symptomatic improvement rate
up to 4 weeks
Endoscopic improvement rate
up to 4 weeks
Fecal calprotectin level
up to 4 weeks
Plasma C-reactive protein level
up to 4 weeks
- +3 more secondary outcomes
Study Arms (1)
Hyperbaric oxygen therapy
EXPERIMENTALPatients who recieve hyperbaric oxygen therapy will be maintained at 2.4 ATA with 100% oxygen for 90 min and then decompressed back to 1 ATA. The treatment duration is 4 weeks and extends to 6 weeks if necessary.
Interventions
Patients were maintained at 2.4 ATA with 100% oxygen for 90 min and then decompressed back to 1 ATA. The treatment duration is 4 weeks and extends to 6 weeks if necessary.
Eligibility Criteria
You may qualify if:
- IPAA performed for ulcerative colitis;
- Pouchitis Disease Activity Index (PDAI) scores ≥7;
- Antibiotic refractory pouchitis(CARP), defined as patients who do not respond to conventional 2-week, single-agent antibiotic therapy including metronidazole,ornidazole,tinidazole, or ciprofloxacin
- years
- Informed consent given
- Able and willing to comply with all trial procedures
- Including prepouch ileitis
You may not qualify if:
- Crohn's disease of the pouch
- Pouchitis after IPAA for FAP
- Isolated cuffitis
- with cocomttant Primary sclerosing cholangitis (PSC)
- Pouch strictures
- Abscess/Sinuses
- Perianal disease
- Active malignancy
- Uncontrolled systemic diseases
- History of noninfammatory disease of the pouch
- Decreased pouch compliance
- Irritable pouch syndrome
- Afferent or efferent limb obstruction
- Needing oral or topical steroid or 5-ASA
- Major physical or psychiatric illness within the last 6m
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
Nanjing, Jiangsu, 210000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jianfeng Gong, MD
Jinling Hospital, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
April 14, 2018
First Posted
May 16, 2018
Study Start
June 1, 2018
Primary Completion
May 1, 2020
Study Completion
July 1, 2020
Last Updated
May 16, 2018
Record last verified: 2018-05